{
"NDC": [
{
"NDCCode": "59651-092-61",
"PackageDescription": "6000 TABLET in 1 BAG (59651-092-61)",
"NDC11Code": "59651-0092-61",
"ProductNDC": "59651-092",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"StartMarketingDate": "20171113",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "12634-092-61",
"PackageDescription": "10 CAPSULE in 1 BLISTER PACK (12634-092-61)",
"NDC11Code": "12634-0092-61",
"ProductNDC": "12634-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. C 18H 33ClN 2O 5SHCl M.W. 461.45. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "37000-092-61",
"PackageDescription": "613 mL in 1 BOTTLE, PLASTIC (37000-092-61) ",
"NDC11Code": "37000-0092-61",
"ProductNDC": "37000-092",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Head And Shoulders",
"ProprietaryNameSuffix": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent recurrence of flaking and itching associated with dandruff."
},
{
"NDCCode": "59651-053-61",
"PackageDescription": "6000 TABLET, FILM COATED in 1 BAG (59651-053-61) ",
"NDC11Code": "59651-0053-61",
"ProductNDC": "59651-053",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20160426",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-04-24",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "26-APR-16"
},
{
"NDCCode": "59651-071-61",
"PackageDescription": "6000 TABLET, FILM COATED in 1 BAG (59651-071-61)",
"NDC11Code": "59651-0071-61",
"ProductNDC": "59651-071",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20171113",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "59651-093-61",
"PackageDescription": "6000 TABLET in 1 BAG (59651-093-61)",
"NDC11Code": "59651-0093-61",
"ProductNDC": "59651-093",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"StartMarketingDate": "20171113",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "59651-191-61",
"PackageDescription": "6000 TABLET, FILM COATED in 1 BAG (59651-191-61) ",
"NDC11Code": "59651-0191-61",
"ProductNDC": "59651-191",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-05-26",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-DEC-17"
},
{
"NDCCode": "59651-308-61",
"PackageDescription": "6000 TABLET, FILM COATED in 1 BAG (59651-308-61) ",
"NDC11Code": "59651-0308-61",
"ProductNDC": "59651-308",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-01-27",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "08-APR-20"
},
{
"NDCCode": "59651-717-61",
"PackageDescription": "6000 TABLET in 1 BAG (59651-717-61) ",
"NDC11Code": "59651-0717-61",
"ProductNDC": "59651-717",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Clorazepate Dipotassium",
"DosageFormName": "TABLET",
"StartMarketingDate": "20230923",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLORAZEPATE DIPOTASSIUM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2024-09-10",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "23-SEP-23"
},
{
"NDCCode": "59651-722-61",
"PackageDescription": "6000 TABLET in 1 BAG (59651-722-61) ",
"NDC11Code": "59651-0722-61",
"ProductNDC": "59651-722",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2023-04-15",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "17-JAN-23"
},
{
"NDCCode": "59651-723-61",
"PackageDescription": "6000 TABLET in 1 BAG (59651-723-61) ",
"NDC11Code": "59651-0723-61",
"ProductNDC": "59651-723",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2023-04-15",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "17-JAN-23"
},
{
"NDCCode": "59651-724-61",
"PackageDescription": "6000 TABLET in 1 BAG (59651-724-61) ",
"NDC11Code": "59651-0724-61",
"ProductNDC": "59651-724",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"StartMarketingDate": "20230117",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2023-04-15",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "17-JAN-23"
},
{
"NDCCode": "59651-973-61",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-973-61) / 6 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "59651-0973-61",
"ProductNDC": "59651-973",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208039",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "59651-974-61",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-974-61) / 6 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "59651-0974-61",
"ProductNDC": "59651-974",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208039",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "59651-975-61",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-975-61) / 6 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "59651-0975-61",
"ProductNDC": "59651-975",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208039",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "59651-260-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-260-01) ",
"NDC11Code": "59651-0260-01",
"ProductNDC": "59651-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "59651-261-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-261-01) ",
"NDC11Code": "59651-0261-01",
"ProductNDC": "59651-261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "59651-261-48",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (59651-261-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59651-0261-48",
"ProductNDC": "59651-261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "59651-262-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-262-01) ",
"NDC11Code": "59651-0262-01",
"ProductNDC": "59651-262",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "59651-262-48",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (59651-262-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59651-0262-48",
"ProductNDC": "59651-262",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "59651-263-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-263-01) ",
"NDC11Code": "59651-0263-01",
"ProductNDC": "59651-263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "59651-263-48",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (59651-263-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59651-0263-48",
"ProductNDC": "59651-263",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "59651-264-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-264-01) ",
"NDC11Code": "59651-0264-01",
"ProductNDC": "59651-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "59651-264-48",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (59651-264-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59651-0264-48",
"ProductNDC": "59651-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20241212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212923",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241212",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine."
},
{
"NDCCode": "0869-0318-09",
"PackageDescription": ".095 L in 1 BOTTLE, PLASTIC (0869-0318-09)",
"NDC11Code": "00869-0318-09",
"ProductNDC": "0869-0318",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Mouth Rinse",
"NonProprietaryName": "Eucalyptol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "19890715",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Vi-Jon",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".092; .042; .06; .064",
"StrengthUnit": "kg/100L; kg/100L; kg/100L; kg/100L",
"Status": "Deprecated",
"LastUpdate": "2018-05-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10056-092-01",
"PackageDescription": "88.5 mL in 1 BOTTLE, SPRAY (10056-092-01)",
"NDC11Code": "10056-0092-01",
"ProductNDC": "10056-092",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Formucare Ultraspeed Sports Advantage",
"NonProprietaryName": "Trolamine Salicylate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Access Business Group LLC",
"SubstanceName": "TROLAMINE SALICYLATE",
"StrengthNumber": "10",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-06-23"
},
{
"NDCCode": "10544-092-06",
"PackageDescription": "6 TABLET in 1 BOTTLE (10544-092-06)",
"NDC11Code": "10544-0092-06",
"ProductNDC": "10544-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090828",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim tablets USP are a synthetic antibacterial combination product available in double strength (DS) tablets, each containing 800 mg sulfamethoxazole USP and 160 mg trimethoprim USP; in tablets, each containing 400 mg sulfamethoxazole USP and 80 mg trimethoprim USP for oral administration. Sulfamethoxazole USP is N1 - (5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. Inactive ingredients: colloidal silicon dioxide, docusate sodium, magnesium stearate, pregelatinized starch, sodium benzoate, sodium starch glycolate and talc."
},
{
"NDCCode": "10544-092-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (10544-092-14)",
"NDC11Code": "10544-0092-14",
"ProductNDC": "10544-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090828",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim tablets USP are a synthetic antibacterial combination product available in double strength (DS) tablets, each containing 800 mg sulfamethoxazole USP and 160 mg trimethoprim USP; in tablets, each containing 400 mg sulfamethoxazole USP and 80 mg trimethoprim USP for oral administration. Sulfamethoxazole USP is N1 - (5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. Inactive ingredients: colloidal silicon dioxide, docusate sodium, magnesium stearate, pregelatinized starch, sodium benzoate, sodium starch glycolate and talc."
},
{
"NDCCode": "10631-092-16",
"PackageDescription": "454 g in 1 BOTTLE (10631-092-16)",
"NDC11Code": "10631-0092-16",
"ProductNDC": "10631-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eurax",
"NonProprietaryName": "Crotamiton",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009112",
"LabelerName": "Ranbaxy Laboratories Inc.",
"SubstanceName": "CROTAMITON",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "10631-092-60",
"PackageDescription": "60 g in 1 BOTTLE (10631-092-60)",
"NDC11Code": "10631-0092-60",
"ProductNDC": "10631-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eurax",
"NonProprietaryName": "Crotamiton",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009112",
"LabelerName": "Ranbaxy Laboratories Inc.",
"SubstanceName": "CROTAMITON",
"StrengthNumber": "100",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59651-092-61</NDCCode>
<PackageDescription>6000 TABLET in 1 BAG (59651-092-61)</PackageDescription>
<NDC11Code>59651-0092-61</NDC11Code>
<ProductNDC>59651-092</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20171113</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12634-092-61</NDCCode>
<PackageDescription>10 CAPSULE in 1 BLISTER PACK (12634-092-61)</PackageDescription>
<NDC11Code>12634-0092-61</NDC11Code>
<ProductNDC>12634-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. C 18H 33ClN 2O 5SHCl M.W. 461.45. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>37000-092-61</NDCCode>
<PackageDescription>613 mL in 1 BOTTLE, PLASTIC (37000-092-61) </PackageDescription>
<NDC11Code>37000-0092-61</NDC11Code>
<ProductNDC>37000-092</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Head And Shoulders</ProprietaryName>
<ProprietaryNameSuffix>Dry Scalp Care</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>LOTION/SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-053-61</NDCCode>
<PackageDescription>6000 TABLET, FILM COATED in 1 BAG (59651-053-61) </PackageDescription>
<NDC11Code>59651-0053-61</NDC11Code>
<ProductNDC>59651-053</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20160426</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-04-24</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-APR-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-071-61</NDCCode>
<PackageDescription>6000 TABLET, FILM COATED in 1 BAG (59651-071-61)</PackageDescription>
<NDC11Code>59651-0071-61</NDC11Code>
<ProductNDC>59651-071</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20171113</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59651-093-61</NDCCode>
<PackageDescription>6000 TABLET in 1 BAG (59651-093-61)</PackageDescription>
<NDC11Code>59651-0093-61</NDC11Code>
<ProductNDC>59651-093</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20171113</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59651-191-61</NDCCode>
<PackageDescription>6000 TABLET, FILM COATED in 1 BAG (59651-191-61) </PackageDescription>
<NDC11Code>59651-0191-61</NDC11Code>
<ProductNDC>59651-191</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-26</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-DEC-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-308-61</NDCCode>
<PackageDescription>6000 TABLET, FILM COATED in 1 BAG (59651-308-61) </PackageDescription>
<NDC11Code>59651-0308-61</NDC11Code>
<ProductNDC>59651-308</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-27</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-APR-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-717-61</NDCCode>
<PackageDescription>6000 TABLET in 1 BAG (59651-717-61) </PackageDescription>
<NDC11Code>59651-0717-61</NDC11Code>
<ProductNDC>59651-717</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20230923</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLORAZEPATE DIPOTASSIUM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2024-09-10</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-SEP-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-722-61</NDCCode>
<PackageDescription>6000 TABLET in 1 BAG (59651-722-61) </PackageDescription>
<NDC11Code>59651-0722-61</NDC11Code>
<ProductNDC>59651-722</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2023-04-15</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-JAN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-723-61</NDCCode>
<PackageDescription>6000 TABLET in 1 BAG (59651-723-61) </PackageDescription>
<NDC11Code>59651-0723-61</NDC11Code>
<ProductNDC>59651-723</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2023-04-15</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-JAN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-724-61</NDCCode>
<PackageDescription>6000 TABLET in 1 BAG (59651-724-61) </PackageDescription>
<NDC11Code>59651-0724-61</NDC11Code>
<ProductNDC>59651-724</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20230117</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2023-04-15</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-JAN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-973-61</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-973-61) / 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0973-61</NDC11Code>
<ProductNDC>59651-973</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208039</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>59651-974-61</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-974-61) / 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0974-61</NDC11Code>
<ProductNDC>59651-974</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208039</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
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<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-975-61) / 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>59651-975</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208039</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The molecular formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.475 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.830 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.950 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hypromellose, lecithin (soya), low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc, tartaric acid pellets, titanium dioxide and xanthan gum. The capsule shell contains carrageenan, FD&C Yellow No. 6, hypromellose, potassium chloride and titanium dioxide. In addition, 110 mg and 150 mg capsule shell contains FD&C Blue No. 2. The capsules are printed with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
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<NDCCode>59651-260-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-260-01) </PackageDescription>
<NDC11Code>59651-0260-01</NDC11Code>
<ProductNDC>59651-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20241212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212923</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
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<NDCCode>59651-261-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-261-01) </PackageDescription>
<NDC11Code>59651-0261-01</NDC11Code>
<ProductNDC>59651-261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212923</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
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<PackageDescription>8 BLISTER PACK in 1 CARTON (59651-261-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDate>20241212</StartMarketingDate>
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<ApplicationNumber>ANDA212923</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<ApplicationNumber>ANDA212923</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
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<PackageDescription>8 BLISTER PACK in 1 CARTON (59651-262-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
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<ProprietaryName>Clozapine</ProprietaryName>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
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<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
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<ApplicationNumber>ANDA212923</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
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<NDCCode>59651-264-01</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20241212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212923</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
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<PackageDescription>8 BLISTER PACK in 1 CARTON (59651-264-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>59651-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212923</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are yellow to pale yellow, and are for oral administration. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The inactive ingredients include aspartame, crospovidone, magnesium stearate, mannitol, polyvinyl acetate, povidone, powdarome peppermint premium, silicified microcrystalline cellulose, sodium lauryl sulfate, sodium stearyl fumarate and yellow iron oxide. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.25 mg aspartame, thus, 0.70 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.40 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 10 mg aspartame, thus, 5.61 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 15 mg aspartame, thus, 8.42 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.23 mg phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>0869-0318-09</NDCCode>
<PackageDescription>.095 L in 1 BOTTLE, PLASTIC (0869-0318-09)</PackageDescription>
<NDC11Code>00869-0318-09</NDC11Code>
<ProductNDC>0869-0318</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Mouth Rinse</ProprietaryName>
<NonProprietaryName>Eucalyptol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19890715</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Vi-Jon</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.092; .042; .06; .064</StrengthNumber>
<StrengthUnit>kg/100L; kg/100L; kg/100L; kg/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-05-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10056-092-01</NDCCode>
<PackageDescription>88.5 mL in 1 BOTTLE, SPRAY (10056-092-01)</PackageDescription>
<NDC11Code>10056-0092-01</NDC11Code>
<ProductNDC>10056-092</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Formucare Ultraspeed Sports Advantage</ProprietaryName>
<NonProprietaryName>Trolamine Salicylate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Access Business Group LLC</LabelerName>
<SubstanceName>TROLAMINE SALICYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-06-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>10544-092-06</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE (10544-092-06)</PackageDescription>
<NDC11Code>10544-0092-06</NDC11Code>
<ProductNDC>10544-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090828</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim tablets USP are a synthetic antibacterial combination product available in double strength (DS) tablets, each containing 800 mg sulfamethoxazole USP and 160 mg trimethoprim USP; in tablets, each containing 400 mg sulfamethoxazole USP and 80 mg trimethoprim USP for oral administration. Sulfamethoxazole USP is N1 - (5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. Inactive ingredients: colloidal silicon dioxide, docusate sodium, magnesium stearate, pregelatinized starch, sodium benzoate, sodium starch glycolate and talc.</Description>
</NDC>
<NDC>
<NDCCode>10544-092-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (10544-092-14)</PackageDescription>
<NDC11Code>10544-0092-14</NDC11Code>
<ProductNDC>10544-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090828</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim tablets USP are a synthetic antibacterial combination product available in double strength (DS) tablets, each containing 800 mg sulfamethoxazole USP and 160 mg trimethoprim USP; in tablets, each containing 400 mg sulfamethoxazole USP and 80 mg trimethoprim USP for oral administration. Sulfamethoxazole USP is N1 - (5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. Inactive ingredients: colloidal silicon dioxide, docusate sodium, magnesium stearate, pregelatinized starch, sodium benzoate, sodium starch glycolate and talc.</Description>
</NDC>
<NDC>
<NDCCode>10631-092-16</NDCCode>
<PackageDescription>454 g in 1 BOTTLE (10631-092-16)</PackageDescription>
<NDC11Code>10631-0092-16</NDC11Code>
<ProductNDC>10631-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eurax</ProprietaryName>
<NonProprietaryName>Crotamiton</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009112</ApplicationNumber>
<LabelerName>Ranbaxy Laboratories Inc.</LabelerName>
<SubstanceName>CROTAMITON</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10631-092-60</NDCCode>
<PackageDescription>60 g in 1 BOTTLE (10631-092-60)</PackageDescription>
<NDC11Code>10631-0092-60</NDC11Code>
<ProductNDC>10631-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eurax</ProprietaryName>
<NonProprietaryName>Crotamiton</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009112</ApplicationNumber>
<LabelerName>Ranbaxy Laboratories Inc.</LabelerName>
<SubstanceName>CROTAMITON</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
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